Cosmetic device maker ilooda said Monday that it had signed a settlement agreement with Serendia LLC to resolve a U.S. International Trade Commission (ITC) investigation.In March 2023, Serendia filed a complaint with the ITC, alleging ilooda’s infringement on its "invasive RF" patent.Invasive RF is
Celltrion said it reported consolidated sales of 2.1 trillion won ($1.5 billion) and operating income of 651 billion won in 2023, down 4.71 percent and up 0.66 percent, respectively, from the previous year.The company also posted a net profit of 539.2 billion won, down 0.53 percent, and an operating
CHA Biotech said it had achieved its highest-ever annual revenue, posting a consolidated revenue of 954 billion won ($798 million) for the year 2023, up 13 percent from the previous year, thanks to strong business performance overseas.Despite the global economic slowdown, CHA Biotech attributed its
NGeneBio, a precision diagnostics platform company, has received approval from the Thai Food and Drug Administration (TFDA) to market HLAaccuTest™ All, an in vitro diagnostic medical device based on next-generation sequencing (NGS) technology.It is the fourth NGS-based product approved for registrat
Biotech companies developing new drugs are plagued by rumors that adversely affect investor sentiment.Faced with a series of speculations about the equity sale by the largest shareholders and plans for a capital increase, SCM Lifescience, ABL Bio, NKMAX, and Genome & Company have responded with offi
Celltrion said it has commenced the first shipment of Zymfentra, the world’s first subcutaneous form of infliximab, to the U.S. targeting autoimmune diseases. The company announced that the initial shipment batch was airlifted today to Atlanta, U.S., with plans to complete three shipment phases by e
CHA Biotech has launched a study to enhance the anticancer efficacy of its natural killer (NK) cell therapeutic drug by making the most of polymer, a cationic compound.The cationic compounds used in the study are synthetic polymers, in which monomers, molecules with low molecular weight, are repeate
Pharos iBio will collaborate with the team of Professor Shin Sang-joon of the Department of Medical Oncology at Yonsei Cancer Center to conduct the translational study of PHI-501 under development for treating solid tumors.PHI-501 is a pipeline of solid tumor therapeutics in preclinical development.
AriBio said Monday that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has formally approved POLARIS-AD, a global phase 3 clinical trial of AR1001, an oral treatment for Alzheimer's disease.AriBio plans to initiate the phase 3 trial in the U.K. before the end of the first quarte
Samsung Bioepis said that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Pyzchiva, also known as SB17, a biosimilar candidate referencing Stelara, last Sunday. This biosimilar, referencing Janssen's Stelara (ingredient: uste
Alteogen, a Kosdaq-listed biotech company, said it has made an amendment to its existing license agreement with the global pharmaceutical company MSD, known as Merck & Co. in the U.S. and Canada.The revised agreement grants MSD exclusive global rights to ALT-B4, a recombinant human hyaluronidase enz
Samsung Bioepis said it has made significant progress with its autoimmune disease treatment biosimilar, SB17, suggesting its potential use across all indications treatable by the original drug, Stelara.Stelara is an interleukin (IL)-12, 23 inhibitor developed by Janssen. It is used to treat inflamma
Samsung Bioepis has begun clinical development of its next flagship pipeline, a biosimilar of Keytruda (pembrolizumab).Samsung Bioepis said Wednesday that the company had initiated a global phase 1 clinical trial of SB27, a Keytruda biosimilar, and its 11th biosimilar pipeline.Samsung Bioepis will r
Gradiant Bioconvergence said Thursday that it has entered into a research collaboration agreement with U.S. messenger ribonucleic acid (mRNA) therapeutics developer Strand Therapeutics to develop next-generation mRNA therapeutics.Under the agreement, the companies will collaborate on developing a fo
Y-Biologics said Wednesday that it has signed a licensing-out deal with VaxCell Bio, a company specializing in anticancer immune cell therapies, for its anti-PD-L1 antibody “YBL-007” sequence.Under the agreement, VaxCell Bio has the exclusive right to use the YBL-007 sequence in the research, develo
Samsung Biologics said it has obtained the "Leadership A-"grade, the second highest of the eight grades, from Carbon Disclosure Project (CDP), a global sustainability assessment organization, for its climate change response efforts in 2023.The company stressed that it is the first in the domestic bi
Celltrion said it has completed its application for marketing authorization to the European Medicines Agency (EMA) for CT-P47, a biosimilar referencing Actemra.Roche's Actemra (ingredient: tocilizumab), known as RoActemra in Europe, is approved for a wide range of conditions, including rheumatoid ar
C-Biomex said Thursday that it has entered into a collaborative research agreement with MD Anderson Cancer Center to proceed with the U.S. investigational new drug (IND) application for its radiopharmaceutical therapy, CBT-001.CBT-001 targets CA-9 (Carbonic anhydrase 9), which is overexpressed in ki
The Seoul High Court on Wednesday upheld the lower court's decision, rejecting Kolon Life Science's appeal to suspend the Ministry of Food and Drug Safety's order cancelling the approval for Invossa-K, a gene therapy for osteoarthritis.This decision marks the second defeat for Kolon Life Science in
Prestige Biopharma said Wednesday that the dosing of its Avastin biosimilar, HD204, conducted by global contract research organization (CRO) IQVIA, will be completed this month.HD204 is being studied in a global phase 3 clinical trial by two leading CROs, enrolling 650 patients in 17 countries world
